CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA‐DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first‐in‐class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been approved by the European Commission for treating adults with EPP.

Based in Melbourne, Australia, CLINUVEL has operations in Europe, the US and Singapore.

About vitiligo

Vitiligo is a common skin disorder in which the pigment producing cells of the skin (melanocytes) are absent or demonstrate lack of activity. As a result, lighter depigmented patches of skin (target lesions) appear in different parts of the body due the lack of melanin (pigment). The exact cause of vitiligo is unknown, but it is generally recognised that an autoimmune component plays a role in this disease. Between 0.1-2% of the global population is affected by vitiligo affecting all races. Vitiligo causes significant psychological and emotional distress.

Vitiligo is traditionally separated into two clinical forms: generalised vitiligo and segmental vitiligo (SV), which present with distinctive clinical features and natural histories.

Generalised vitiligo (or just 'vitiligo', previously referred to as 'nonsegmental vitiligo')* is the most common form of the disease, accounting for 72-95% of the cases. The vitiliginous lesions are usually symmetrically distributed and new patches may appear throughout the patient’s life. The disease is progressive with flare-ups. Vitiligo is frequently associated with personal or family history of auto-immunity.

SV is characterised by a unilateral distribution that may totally or partially match a dermatome (area of skin with innervation from a single spinal nerve) and has an earlier onset and a rapid spread. SV occurs in a minority of patients and is thought to be more frequent in pediatric patients; it may account for 30% of childhood cases. Auto-immune association is rare with SV.

The main goal of treating vitiligo is to achieve an arrest of the depigmentation or even arrive at repigmentation of the unpigmented lesions. Many treatment options exist but clinical challenges persist, as not all patients respond to available therapies and relapse is common.

CLINUVEL commenced a pilot Phase II trial of SCENESSE® (afamelanotide 16mg) as a repigmentation therapy in patients with generalised vitiligo in the USA and Europe in the second quarter of 2011. SCENESSE® is being evaluated for its ability to activate melanocytes within the vitiliginous lesions and achieve repigmentation in combination with NB-UVB in patients with vitiligo. The first treatment results from this program, study CUV102, were announced in December 2012. A Phase IIb study of the drug commenced in Singapore in 2014.

The introduction of SCENESSE® (afamelanotide 16mg) in vitiligo treatment

* Since the commencement of CLINUVEL's clinical program it has been agreed by the international medical community that ‘nonsegmental vitiligo’ no longer be used to describe the most common form of the disease, which is now referred to as ‘vitiligo’.

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